Label: ALPHA FOAMING E-2- benzalkonium chloride soap
- NDC Code(s): 65585-514-01, 65585-514-02
- Packager: Whisk Products, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated April 28, 2020
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- Active Ingredient
For external use only.
When using this product, avoid contact with eyes. In case of eye contact, flush eyes with water.
Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ALPHA FOAMING E-2
benzalkonium chloride soap
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65585-514 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color white (colorless, water-white (dispensed as a white foam)) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65585-514-01 4 in 1 BOX 04/23/2020 1 1000 mL in 1 BAG; Type 0: Not a Combination Product 2 NDC:65585-514-02 8 in 1 BOX 04/23/2020 2 1000 mL in 1 BAG; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 04/23/2020 Labeler - Whisk Products, Inc. (834270639) Establishment Name Address ID/FEI Business Operations Whisk Products, Inc. 834270639 manufacture(65585-514)